NCT02245880

Brief Summary

Intubation must be done with utmost care in cervical trauma patients. cervical spine motion must be minimized and intubation must be fast. The aim of this study was to compare the effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients undergoing elective surgery were enrolled in this trial. After standard monitorisation including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were divided into two groups glidescope and fastrach. Rigid collar was placed then patients were intubated with one of these devices. Mask ventilations with or without collar were recorded. insertion times, intubation times of the devices were recorded. Peroperative hemodynamic parameters and postoperative minor complications were also recoded.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 22, 2014

Completed
Last Updated

April 1, 2015

Status Verified

March 1, 2015

Enrollment Period

5 months

First QC Date

April 17, 2014

Last Update Submit

March 31, 2015

Conditions

Injury of Cervical Spine

Keywords

cervical spineintubating laryngeal mask airwayGlidescope videolaryngoscopecollar

Outcome Measures

Primary Outcomes (1)

  • intubation times

    From handling of the device till intıbation

Secondary Outcomes (2)

  • Heart rate

    From Preoperative heart rate till 15 minutes After intubation

  • Mean arterial pressure

    From preinduction till 15 minutes after intubation

Other Outcomes (2)

  • minor complications

    From the end of surgery till 2 hours postoperatively

  • Mucosal damage

    Bloodstain on the device after removal

Study Arms (2)

Glidescope videolaryngoscope

ACTIVE COMPARATOR

cervical collar was applied to 47 patients then facemask ventilations were recoded intubated with Glidescope and insertion time: handling of the device till the good glottic visualisation intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device after removal heart rate preinduction heart rate postinduction heart rate postinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation wrere recorded. postoperative minor complications were recorded.

Device: Glidescope

Intubating laryngeal mask airway

ACTIVE COMPARATOR

cervical collar was applied to 47 patients then facemask ventilations through the collar were recorded and intubated with ILMA insertion time: handling of the device till the good glottic visualisation appears intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device heart rate preinduction heart rate postinduction heart rate posinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation

Device: ILMA

Interventions

GlidescopeDEVICE

videolaryngoscope

Glidescope videolaryngoscope
ILMADEVICE

handling of the device till the optimal ventilation achieved

Also known as: FASTRACH
Intubating laryngeal mask airway

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • ASA I-II
  • requiring intubation
  • BMI\<35

You may not qualify if:

  • less than 18 or higher than 65
  • ASA III-IV
  • BMI\> 35
  • PREGNANT
  • head and neck tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University School of Medicine

Kocaeli, 41900, Turkey (Türkiye)

Location

Study Officials

  • Zehra I ARSLAN, Specialist

    Anesthesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 17, 2014

First Posted

September 22, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 1, 2015

Record last verified: 2015-03

Locations

TU(1)